부산대학교 도서관

Summary: Background: Spontaneous HDV‐RNA fluctuations, assessed by nonstandardised in‐house assays, have been reported during the course of chronic hepatitis delta (CHD). Aims: To evaluate changes in serum HDV‐RNA concentrations in untreated CHD patients and correlate these changes with other HBV markers. Methods: A total of 323 consecutive serum samples from 56 CHD patients (detectable HDV‐RNA) followed for >3 years were retested for HDV‐RNA levels by a sensitive technique using the first WHO international HDV‐RNA standard. Quantitative HBsAg, HBV‐DNA, and HBV‐RNA were also determined. Results: Most participants were male, middle‐aged, white European, and HBeAg‐negative (82%). Almost half had liver cirrhosis and 64% were receiving nucleos(t)ide analogues. At inclusion, median‐HDV‐RNA was 5.3 (4.2‐6.5) log10IU/mL, HBsAg 4.0 (3.5‐4.3) log10IU/mL, and HBV‐DNA 1.6 (1.0‐2.6) log10IU/mL; ALT values were normal in 13 (23%). During a mean follow‐up of 5.6 (3‐16) years, 14 (25%) showed ≥2log10 HDV‐RNA decline, including 11 (20%) who spontaneously achieved undetectable HDV‐RNA. Four patients (7%) lost HBsAg, with undetectable HDV‐RNA. The remaining 42 (75%) had persistently detectable HDV‐RNA. During follow‐up, patients with a ≥2log10 HDV‐RNA decline showed a greater HBsAg drop (−0.7 ± 1.1 vs −0.09 ± 0.9 log IU/mL; P = 0.039) than those with a <2 log10 HDV‐RNA decline. Overall, ALT and HBV‐DNA levels decreased over time. There were no differences in clinical outcomes between groups. Conclusions: One‐quarter of untreated CHD patients showed a ≥2log10 decline in HDV‐RNA and 20% reached HDV‐RNA undetectability during a mean follow‐up of 5.6 years. The decline was associated with ALT decrease. These findings have implications for designing new therapies for CHD. [ABSTRACT FROM AUTHOR]